510(k) Report

Devices descending from K022365

125 later devices reach Stryker Navigation System - Hip Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K201149CoLink Plating SystemIn2bones USA, LLC20200—
+9K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+9K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+9K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+10K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+10K252246Leforte MMF SystemJeil Medical Corporation20260—
+10K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+10K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+10K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+10K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+10K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+10K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+10K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+10K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+10K192592Axis Plating SystemExtremity Medical, LLC20190—
+10K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+11K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+11K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+11K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+11K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+12K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+12K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+12K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+13K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+14K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—